Label: PHYTO MICELLAR OTIC CLEANSER- phytosphingosine hydrochloride solution
- NDC Code(s): 11695-7239-4, 11695-7239-8
- Packager: Butler Animal Health Supply, LLC dba Covetrus North America
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 6, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
Phyto micellar Otic Cleanser
Active ingredient: Phytosphingosine HCI 0.02%
Ingredients: Water, polysorbate-80, SD alcohol 40-B, propylene glycol, laureth-9, poloxamer 184, imidazolidinyl urea, phenoxyethanol, potassium sorbate, biosaccharide gum-2, citric acid, fragrance.
Properties: Phyto micellar otic cleansing solution contains micellar technology and soothing agents to help emulsify and wash out waxy debris without drying the skin. The solution is also non-greasy and non-staining. It also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
Indications: For use in dogs and cats only. Ideal for cleaning the ear canal, eye contours, and skin folds. May also be used to clean soiled and matted hair, or greasy skin associated with seborrheic conditions.
Directions for use: Shake well before use. For ear cleaning, ask your veterinarian which of the two following protocols is best for your pet:
1) Moisten a cotton ball with solution and place in the entrance of the ear canal; or
2) Hold the ear flap upwards and fill the ear canal with solution.
Then gently massage the base of the ear for 60 seconds. Remove the cotton ball (if used) and allow the pet to shake its head. Gently wipe away debris and excess solution with a clean, dry cotton ball.
To clean other areas of the skin, moisten a cotton ball or gauze with the solution and gently wipe the area to cleanse and remove debris. Repeat as necessary until clean.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 125 mL BOTTLE
- PRINCIPAL DISPLAY PANEL - 250 mL BOTTLE
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INGREDIENTS AND APPEARANCE
PHYTO MICELLAR OTIC CLEANSER
phytosphingosine hydrochloride solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7239 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SEC-LAURETH-9 (UNII: 441JX1IO3Z) POLOXAMER 184 (UNII: BIS92ZSF57) BIOSACCHARIDE GUM-2 (UNII: UVQ34I5XKQ) IMIDUREA (UNII: M629807ATL) PHENOXYETHANOL (UNII: HIE492ZZ3T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7239-4 125 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-7239-8 250 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2020 Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329) Registrant - Ceva Sante Animale (261126049)
